A two part first-in-human phase I study (with expanded cohorts) with the antibody-drug conjugate SYD985 to evaluate the safety, pharmacokinetics and efficacy in patients with locally advanced or metastatic solid tumours. - SYD985.001

Synthon Biopharmaceuticals BV0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月23日

研究概览

暂无简介。

•1. Patient with histologically-confirmed, locally advanced or metastatic tumour
•who has progressed on standard therapy or for whom no standard therapy exists,
•whith the following restriction:
•- Part I: solid tumours of any origin
•- Part II: breast and gastric tumours, including adenocarcinomas of the
•gastroesophageal junction, urothelial and endometrial tumours;
•2. For Part II: HER2 tumour status as defined in the protocol
•3. ECOG performance status <= 1
•4. Life expectancy > 12 weeks
•5. Adequate organ function
•6. For Part II: measurable disease
•7. For Part II only: Presence of a tumour lesion accessible for biopsy and
•willingness to undergo a fresh tumour biopsy, unless biopsy material is
•available from a metastatic lesion obtained not more than 6 months prior to
•signing informed consent.

•1. Anthracycline treatment within 3 months and/or abnormal cardiac biomarker
•2. Other anticancer therapy (except for LHRH agonists) within 4 weeks (6 weeks
•for nitrosoureas and mitomycin C)
•3. History of infusion-related reactions and/or hypersensitivity to
•trastuzumab, trastuzumab emtansine
•4. Severe, uncontrolled systemic disease
•5. LVEF < 55%, or a history of absolut decrease in LVEF of >= 10% points to <
•50% during previous treatment with trastuzumab or trastuzumab emtansine, or a
•history of decrease in LVEF to < 40% during previous treatment with trastuzumab
•or trastuzumab emtansine
•6. History of clinically significant CV disease
•7. Symptomatic brain metastases, or therapy for brain metastases (excluding PCI
•and dexamethasone treatment with stable or decreasing daily dose) within 4

发起方

Synthon Biopharmaceuticals BV